| southeasteyecare@hotmail.com 2006-10-14, 4:28 pm |
| VII. PATIENT SATISFACTION
LASIK success is measured by the LASIK industry as uncorrected visual
acuity under bright illumination. Patients seeking vision correction
are most concerned with elimination of glasses or contact lenses, and
are unaware what it means to lose visual quality. Patient surveys
typically show a high level of satisfaction with LASIK. However, an
alarming number of 'satisfied' patients also report symptoms such
as visual disturbances in dim light and dry eye.
In May, 2001, results from a questionnaire completed by PRK and LASIK
patients revealed that 19.5% reported a worsening in functioning, 27.1%
a worsening in symptoms, 34.9% a worsening in optical problems, 33.7% a
worsening in glare, and 41.5% a worsening in driving.27
In one report, researchers suggest that factors such as the Hawthorne
effect and cognitive dissonance may play a role in patient satisfaction
following LASIK.28 The Hawthorne effect favorably influences
patients' survey responses merely because patients are aware that
they are enrolled in a study. Cognitive dissonance is a change in
one's attitude or beliefs to eliminate internal conflict with
negative consequences of an irreversible action.
VIII. NEWER TECHNOLOGIES
Wavefront-guided and wavefront-optimized LASIK
Newer laser technologies were designed to reduce induction of new
aberrations and prevent night vision disturbances. As complications
from current technologies generate bad publicity, pressures to develop
and market alternative technologies emerge. "Real" complication
rates are openly discussed, not when a procedure is popular, but rather
when providers push newer, "improved" technology. The LASIK
industry and LASIK surgeons aggressively promote new technologies as
"safer and more effective", blaming older technologies for past
complications. Although the introduction of wavefront-LASIK was
surrounded by hype, studies have shown that wavefront-guided and
wavefront-optimized LASIK actually increase, not decrease, higher order
aberrations, reducing visual quality in previously untreated eyes.29,30
A recently published review of literature on wavefront-guided LASIK
concludes that evidence does not support claims that wavefront
outperforms conventional LASIK.31 Wavefront, like previous forms of
refractive surgery, fails to deliver on its promises.
Femtosecond laser flap creation (Intralase-LASIK)
Mechanical blade microkeratomes have been linked to flap complications
and damage to the epithelium. The femtosecond laser keratome is
currently promoted as a safer alternative. Studies have shown that the
femtosecond laser produces flaps with smaller deviations from planned
thickness than mechanical microkeratomes. However, it does not reduce
most complications associated with the LASIK procedure and has been
linked to extreme light sensitivity,32 a new complication of this
technology. Femtosecond laser flaps are more difficult to lift than
flaps created with a blade, which may result in a higher incidence of
torn flaps.
The femtosecond laser keratome currently requires longer suction on the
eye than blade microkeratomes to create the LASIK flap. The incidence
of posterior vitreous detachment with blade microkeratomes is high, at
13% overall and 24% for patients with high myopia.33 Increased suction
ring exposure associated with use of femtosecond lasers likely induces
posterior vitreous detachment at even higher rates as well as other
serious complications such as retinal detachment, macular hemorrhage,
retinal vein occlusion, and optic nerve damage following LASIK.
A search of peer-reviewed literature reveals problems associated with
the femtosecond laser such as slipped flaps, interface inflammation,
flap folds, infectious keratitis, corneal stromal inflammation, delayed
wound healing, macular hemorrhage, and gas bubbles in the anterior
chamber after surgery.34-40 The FDA medical device adverse events
database (http://www.fda.gov/cdrh/maude.html) contains numerous reports
involving femtosecond laser keratomes.
IX. CONCLUSION
Patients are denied the whole truth about the negative effects of
LASIK; therefore they are unable to give informed consent. The LASIK
industry has been unresponsive to results of medical research, which
should have resulted in a higher standard of care. Instead, LASIK
surgeons have resisted raising the standard of care in order to
maintain the potential pool of candidates and to protect themselves
from liability.
The American Medical Association endorses certain principles of medical
ethics. One principle states that: "A physician shall uphold the
standards of professionalism, be honest in all professional
interactions, and strive to report physicians deficient in character or
competence, or engaging in fraud or deception, to appropriate
entities." (http://www.ama-assn.org/ama/pub/category/2512.html). The
white wall of silence called for by Dr. McDonald in 1999 violates this
principle.
There has been and continues to be a pattern within the refractive
surgery industry placing patients' interests secondary to financial
interests. Medical doctors are ethically bound to put the best
interests of patients first. LASIK is an unnecessary surgical procedure
that permanently damages the eyes of every patient; therefore it is a
violation of a primary principle of medicine, "First, Do No Harm". As
such, the practice of LASIK should be discontinued.
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